Mylan Recalls Gemcitabine for Injection Due to Particulate Matter
Mylan Institutional LLC is recalling 10,094 vials of Gemcitabine for Injection due to the presence of particulate matter.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a score of 4 or higher.
Plain-English summary
Mylan Institutional LLC is recalling 10,094 vials of Gemcitabine for Injection, USP, 1 g/vial. The product is a lyophilized powder in a single-use vial, intended for prescription use only. The recall is being conducted because of the presence of particulate matter in the product.
The affected product is identified by NDC 67457-462-01 and UPC 3 67457 46201 1. The specific lots involved are 7801273 and 7801284, with an expiration date of 05/16. The product was manufactured in India for Mylan Institutional LLC, located in Rockford, IL.
The recalled vials were distributed nationwide and in Puerto Rico. Healthcare providers and patients should stop using the affected product and contact Mylan Institutional LLC for further instructions.
The recalled product
- Product
- Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 10,094
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 7801273
- 7801284
- Exp 05/16
Distribution
Part of a larger recall action
This product is one of 3 recalled by Mylan Institutional LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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